About this trial
A joint opinion of the SFED and the SF2H recommends to orient our colonoscopy practices towards the use of bacteriologically controlled water in reusable bottles for colonic irrigation. To date, no study exists to validate the proposed set-up. Our main objective is therefore to evaluate the microbiological safety of the use of bacteriologically controlled water, in particular the absence of retro contamination of the water in the wash bottle by the faecal flora of the patient undergoing colonoscopy, in order to be able to generalise this practice
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients with a colonoscopy indication whose examination is scheduled in room 4, on a Monday and Tuesday shift (8:30 a.m. - 1:30 p.m.)
Male or female of legal age at the time the colonoscopy is ordered
Patient willing to participate in the study
Person affiliated with or benefiting from a social security plan
Disqualifiers
Pregnant woman
Patient of legal age under guardianship or protected person
Patient requiring indigo-carmine chromoendoscopy
Patient requiring an emergency colonoscopy
Trial design
Single group
Treatments tested in this trial
Colonoscopy with Bacteriological Controlled Water
Procedure/SurgeryPatient with coloscopy which used Bacteriological Controlled Water : Collection of 250 ml of bacteriologically controlled water from the wash bottle at the end of each water-assisted colonoscopy to test for enterobacteria and fecal streptococci
Treatment groups
Trial outcomes
Primary outcomes
Rate of back contamination
Rate of back contamination after colonoscopy using the EBM procedure. The absence of retro-contamination is defined as the absence of fecal flora (enterobacteria and fecal streptococci) in the wash bottle during the bacteriological analysis of the EBM microbiological samples taken after each colonoscopy
Secondary outcomes
Workload
Estimation of the workload in minutes, per person involved and for each phase of the reusable vial circuit
Satisfaction and acceptability healthcare professionals
Evaluation of satisfaction and acceptability among healthcare professionals using the French version of the System Usability Scale (FSUS).
Acceptability patient
Assessment of patient acceptability of Bacteriologically Controlled Water use by counting the total number of patients offered the study to obtain 40 consents
Infectious episode
Monitoring the occurrence of an infectious episode (D+1 and D+7) characterized by the occurrence of a fever episode higher than 38.5°C.
Sponsors and contacts
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